A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-escalating Study to Assess Safety, Tolerability and Pharmacokinetics of 0.1% and 1.0% ZEP-3 Cream, Administered Topically in Healthy Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Topical skin safety evaluation
研究概览
简要总结
It is a phase I randomized, double blind, placebo-controlled, dose-escalating study to assess safety, tolerability and pharmacokinetics (PK) data of 0.1% and 1.0% ZEP-3 cream, administered topically up to 5 consecutive treatment days in healthy volunteers.
This is a single center trial. It is anticipated that the study will be conducted at the Department of Dermatology, at the Sheba Medical Center, Ramat Gan, Israel.
The screening/enrollment visit includes a PK study for 24h following a single IP topical application. After a 24h washout time break, the subject will enter the treatment period for 5 consecutive treatment days followed by a follow up visit 1 and 5 days after end of treatment.
详细描述
The primary endpoints of this study are:
- Safety evaluation - To demonstrate ZEP-3 cream safety in terms of skin irritation score.
- Safety evaluation - To demonstrate ZEP-3 cream safety in terms of type and severity of reported adverse events.
- Tolerability evaluation - To demonstrate ZEP-3 cream tolerability in terms of treatment compliance by the treated volunteers.
The secondary endpoints of this study are:
- Systemic absorption PK profile.
- Dermal absorption PK profile (Optional).
Subject safety will be assessed following treatment by ZEP-3 cream, using measurements of the following variables:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must voluntarily sign and date the written Informed Consent prior to any study specific procedures
- •Subject, either men or women is between 18 and 50 years of age.
- •Subject, Body mass index (BMI) is within the normal to overweight range (See appendix 2)
- •Subject must have healthy skin on which reddening can be easily recognized in the area where they will place the test article
- •Subject must be free from a condition/disease that the investigator feels interferes with the interpretation of the study results.
- •Subject is willing to participate in the study and adhere to the study protocol
- •Females of childbearing potential should either be surgically sterile, or should use a highly effective medically accepted contraceptive regimen.
排除标准
- •Subject has hyper- or hypo-pigmentation, or tattoos in the area where they will place the test fields
- •Dark skinned persons whose skin color prevents ready assessment of skin reactions
- •Subject with history of skin disorders or any active skin condition involving the test fields including but not limited to bacterial, viral, or fungal skin infections, acne, rosacea
- •UV therapy or significant UV exposure in the four weeks before treatment application
- •Subject with renal failure (Cr > 2 mg/dl) or Subject with impaired hepatic function (ALT, AST 2-fold higher than normal upper limit value).
- •Cardiac disease, including recent myocardial infarction, any degree of heart block or other cardiac arrhythmias and valvular heart disease
- •Subject suffers from an autoimmune disease (Diabetes, Lupus. Chron ect.)
- •History of malignancy
- •Sever illness or surgery within the previous 3 months (except for minor cosmetic or dental procedures)
- •Treatment with any investigational agent in another clinical trial within 1 month prior to start of this study.
- •Female subject who is pregnant , lactating, or with a positive pregnancy test
- •History of drug or alcohol abuse (as defined by the Investigator)
研究组 & 干预措施
0.1% ZEP-3 cream
250 mg of ZEP-3 Cream 0.1% is applied on the right ventral forearm and 250 mg placebo is applied on the left ventral forearm 4 times daily
干预措施: 0.1% ZEP-3 cream (Drug)
placebo
250 mg of ZEP-3 Cream 1.0% is applied on the right ventral forearm and 250 mg placebo is applied on the left ventral forearm 4 times daily
干预措施: placebo (Drug)
结局指标
主要结局
Topical skin safety evaluation
时间窗: Change in skin clinical presentation up to 5 consecutive treatment days
Skin irritation
次要结局
- Systemic absorption(During 24 hours following initial application)